Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis

NCT04210687 | Active Not Recruiting

• 1 other identifier: TEvsTLE
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients.

Conditions

Thumb Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in pain on load NRS (numerical rating scale)

  Change in rated pain on load from preoperatively to 1, 3 and 5 years postoperatively

  Preoperatively, 1, 3 and 5 years postoperatively

Secondary Outcomes (8)

• Change in Nelson Thumb score

  Preoperatively, 1, 3 and 5 years postoperatively

• Change in EQ-5D

  1, 3 and 5 years postoperatively

• Change in DASH - Disability of the Arm, Shoulder and Hand

  Preoperatively, 1, 3 and 5 years postoperatively

• Change in PRWHE - Patient-Rated Wrist and Hand Evaluation

  Preoperatively, 1, 3 and 5 years postoperatively

• Change in HADS - Change hospital Anxiety and Depression score

  Preoperatively, 1, 3 and 5 years postoperatively

Study Arms (2)

Trapeziectomy

ACTIVE COMPARATOR

Standard simple trapeziectomy, no pins.

Procedure: Trapeziectomy

trapeziometacarpal limited excision

ACTIVE COMPARATOR

Trapeziometacarpal limited excision; Narrow pseudarthrosis of the trapeziometacarpal joint.

Procedure: trapeziometacarpal limited excision

Interventions

trapeziometacarpal limited excision PROCEDURE

Narrow pseudarthrosis CMC1

trapeziometacarpal limited excision

Trapeziectomy PROCEDURE

Simple trapeziectomy

Trapeziectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test).
• Pain at rest.
• Conservative treatment \>6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection)

You may not qualify if:

• Rheumatoid arthritis.
• Ongoing infection in the hand or wrist. -
• History of gout or pseudo gout.
• Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
• Intra-articular injection in the affected joint within 6 months.
• Eaton Littler class 4 (STT joint involved).

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, S-11883, Sweden

Location

Study Officials

• Maria Wilcke, MD PhD

  Karolinska Instituet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 26, 2019
• Study Start: March 9, 2020
• Primary Completion: February 1, 2026
• Study Completion (Estimated): May 30, 2028
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)